MEDTRONIC SINGAPORE OPERATIONS LINQ II¿ INSERTABLE CARDIAC MONITOR; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
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Model Number LNQ22 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Erosion (1750)
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Event Date 02/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported by the implantable cardiac monitor (icm) patient that the device had eroded out of their body.The icm had been implanted twenty five days and was removed. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was further reported that prior to erosion, the patient had significant bruising and bumped the insertion site on their car.Following removal the patient was treated with antibiotics.
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